Self-cinching surgical clips and delivery system

ABSTRACT

A device and method for deploying self-cinching surgical clips. The device accesses at least two layers of tissue or material from only one side of the tissue or material and punctures through the two layers of tissue or material. The various configurations of clips disclosed herein are made of a superelastic material such as Nitinol, and have a constrained and a relaxed state, and no sharp edges or tips so as to reduce tissue irritation following deployment. The clip is disposed within the housing of the delivery device and held in a constrained state by a tube assembly until deployment wherein the clip assumes its relaxed state, where the ends of the clip are brought into close approximation, thereby securing the layers of tissue or material together.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.13/693,952, filed Dec. 4, 2012, now U.S. Pat. No. 8,968,336, whichclaims the benefit of U.S. Patent Application No. 61/568,048, filed Dec.7, 2011, the disclosures all of which are incorporated by reference intheir entireties.

FIELD OF THE INVENTION

The present invention relates generally to the field of medical devices.More particularly, this application relates to self-cinching clips andclip delivery systems for use in surgical procedures.

BACKGROUND OF THE INVENTION

Prosthetic heart valves are used to replace damaged or diseased heartvalves. The natural heart valves are the aortic, mitral (or bicuspid),tricuspid and pulmonary valves. Prosthetic heart valves can be used toreplace any of these naturally occurring valves. Repair or replacementof the aortic or mitral valves is most common because they reside in theleft side of the heart where pressures are the greatest.

Where replacement of a heart valve is indicated, the dysfunctional valveis typically cut out and replaced with either a mechanical valve or atissue valve. Typically, an artificial valve has flexible (e.g.,bioprosthetic) leaflets attached to a wireform structure with arcuatecusps and upstanding commissures supporting the leaflets within thevalve. The artificial valve also has an annular stent and a soft sewingring for better attachment to and sealing against the native valveannulus. The alternating cusps and commissures mimic the natural contourof leaflet attachment. Importantly, the wireform provides continuoussupport for each leaflet along the cusp region so as to better simulatethe natural support structure.

In a typical prosthetic heart valve implantation, approximately 12-18sutures are placed through the patient's native valve annulus. Thesesutures are subsequently passed through the sewing ring of theprosthetic valve outside of the surgical cavity. The valve is then“parachuted” down these sutures to the point where it meets the targetannulus. At that point, the sutures are tied to secure the prosthesis tothe heart. The process of placing the sutures through the annulus andsubsequently tying 3-10 knots per suture is very time consuming andgreatly adds to the time the patient is on heart-lung bypass,anesthesia, etc. There is a direct correlation between time spent onheart-lung bypass and poor outcomes. Additionally, for mitral valves,there is the possibility of “suture looping” to occur during knot tyingin which the suture is looped over a valve commissure and partiallyconstrains a pair of valve leaflets, thus preventing normal function ofthe prosthesis.

Various methods of attaching a prosthetic heart valve to a heart withfew or no sutures have been developed in the past. Attempted attachmentmethods include the utilization of hooks or barbs integrated into theprosthesis that bite into the native tissue to anchor the device. Thesedevices have bulky delivery systems and it can be difficult to positionthe prosthesis accurately.

Another possible solution is to implant a valve in much the same way astraditionally done with sutures, but to replace most or all of thesutures with rapidly deploying clips to attach the sewing ring to theannulus. Past designs have disclosed instrumentation that would deploy aclip with sharpened edges necessary to puncture the tissues or materialsthat are to be secured together. Such designs with sharp-ended clipshave created local tissue irritation due to the exposed ends.

Most of the current devices, such as those disclosed in U.S. Pat. Nos.5,480,406; 6,913,607; 7,407,505; and 7,862,572 all require access toboth sides of the tissue/structures which are being sewn/clippedtogether. This is of particular disadvantage in attaching a prostheticheart valve to an annulus because the prosthetic valve impedes access tothe inflow side of the annulus.

It would therefore be desirable to develop a method of attaching aprosthetic heart valve to a valve annulus with few or no sutures, usinga smaller device to deliver the clips which requires access to only oneside of the target. It would also be advantageous to have a deploymentmechanism with a clip with no sharp edges or tips so as to reduce tissueirritation.

SUMMARY OF THE INVENTION

The present invention provides an instrument for use in intricate,minimally-invasive procedures. More specifically, the present disclosurediscusses a device for securing a surgical clip to secure at least twolayers of tissue and/or synthetic materials together, for example, tosecure a sewing ring of a prosthetic heart valve to a native valveannulus.

In some embodiments the delivery device comprises a housing, a pusherassembly, and a substantially straight tube assembly. A self-cinchingclip made of a super-elastic material is disposed within the tubeassembly, said clip having a relaxed configuration and a constrainedconfiguration. The tube assembly comprises an outer tube and inner tubeslidably disposed within the outer tube, the inner tube having asharpened end configured to puncture at least two layers of tissue ormaterial. In some embodiments, the outer tube comprises a sharpened endconfigured to puncture the at least two layers of tissue or material.The outer tube can include a stop flange. The device can further includea revolving cylinder holding at least one clip, where each clip is in aseparate chamber and each chamber is arranged around the perimeter ofthe revolving cylinder.

The self-cinching clip preferably is made of Nitinol (highly flexibleNi—Ti alloy). In its relaxed state the ends of the clip are brought intoclose approximation. For instance, the clip can have a spiral shapehaving two open ends terminating at different but closely-spacedlocations, or a circular shape with two ends terminating atapproximately the same location, or a semicircle shape with two ends ofthe clip overlapping.

The present invention also provides for a method for securing at leasttwo layers of tissue or material together comprising the steps of:advancing a securing device toward at least two layers of tissue ormaterial, the securing device containing a clip and a tube assembly,wherein the tube assembly has a sharpened end and wherein the clip ismade of a super-elastic material and is constrained in a substantiallystraight position within the tube assembly; puncturing from only oneside of the at least two layers of tissue or material through the atleast two layers of tissue or material using the sharpened end of thetube assembly; and deploying said clip into the at least two layers oftissue or material, wherein the clip returns to its relaxed shape as itexits the tube assembly such that the ends of the clip are brought intoclose approximation, thereby securing the at least two layers together.

A further understanding of the nature and advantages of the presentinvention are set forth in the following description and claims,particularly when considered in conjunction with the accompanyingdrawings in which like parts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be explained and other advantages and featureswill appear with reference to the accompanying schematic drawingswherein:

FIG. 1 is a perspective view of one embodiment of a surgical clipdelivery system.

FIG. 2 is a cross-sectional view of the clip delivery system of FIG. 1.

FIGS. 3A-3B are cross-sectional views of the clip delivery system inseveral stages of operation to eject a clip therefrom.

FIG. 4 is a perspective view of a variation of the distal end of theclip delivery device of FIG. 1, showing an outer tube, an inner tube andclip release slots in each.

FIG. 5 is an enlarged view of the distal end of the outer tube of theclip delivery device.

FIG. 6 is an enlarged view of the distal end of the inner tube of theclip delivery device.

FIG. 7A is a perspective view of the distal end of the clip deliverydevice of FIGS. 4-6 showing an exemplary clip loaded into the inner tubeof the clip delivery device prior to deployment.

FIG. 7B is a perspective view of the distal end of the clip deliverydevice of FIGS. 4-6 showing an exemplary clip exiting the inner tube ofthe clip delivery device during deployment.

FIG. 8 is a perspective view of a semicircle-shaped clip embodiment ofthe present invention.

FIG. 9 is a perspective view of a spiral-shaped clip embodiment of thepresent invention.

FIG. 10 is a perspective view of a circular-shaped clip embodiment ofthe present invention.

FIG. 11 is a perspective view of the distal end of the clip deliverydevice of FIGS. 4-6 illustrating the sequential steps of deploying acircular clip into two layers of tissue and/or synthetic materials.

FIG. 12 is a perspective view of the distal end of the clip deliverydevice of FIG. 1 illustrating the sequential steps of deploying a spiralclip into two layers of tissue and/or synthetic materials.

FIG. 13 is a perspective view of a prosthetic heart valve implantsecured within a native heart valve annulus with the clips describedherein.

FIGS. 14A-14C are cross-sectional views through an alternative clipdelivery system having a cartridge that holds multiple clips, and FIG.15 is an elevational view of the cartridge showing it rotating topresent a new clip to be delivered.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description refers to the accompanying drawings, whichillustrate specific embodiments of the invention. Other embodimentshaving different structures and operation do not depart from the scopeof the present invention.

Described herein is a surgical clip delivery device, which includes aself-closing surgical clip made of a superelastic or shape-memorymaterial such as Nitinol, and methods for delivering the clip to asurgical site. While the device will be described in connection with aheart valve replacement procedure, it is to be understood that thedevice can be used in general surgery or in any procedure where two ormore materials or layers are joined together. Its use is thus notlimited to the surgical replacement of cardiac valves.

The self-closing surgical clip is designed such that when it is deformedinto a configuration for delivery, the strains in the clip are below theyield point of the superelastic material. The clip is held within thedelivery device in a constrained state and returns to its relaxed stateonce it is deployed from the delivery device. Specifically, when theclip is released from its constrained state, it returns or transitionstoward its relaxed shape where the ends of the clip are brought intoclose approximation, thereby securing multiple layers of tissue ormaterial together. It should be understood that intervening tissue ormaterial may impede the clip from entirely resuming its relaxed shape,though the clips are designed to revert as near as possible to theirrelaxed states and thereby fasten the layers of tissue or materialtogether.

FIGS. 1 and 2 illustrate an exemplary embodiment of a surgical clipdelivery device 10. The device 10 comprises a housing 18 having aproximal end (to the right) and a distal end (to the left). A pusherassembly 16 includes a pusher handle 20 and a pusher shaft 26. Thedistal end of the device 10 contains a distal wall 12 through which anouter tube 24 and a hollow inner needle 28 extend distally from agraspable hub 22. The outer tube 24 is mounted for longitudinal movementthrough a bore in the distal wall 12 in the distal end of the housing18, and the inner needle 28 slides within the lumen of the outer tube24, as shown in cross-section in FIG. 2. Furthermore, the graspable hub22 has a nipple 23 that removably couples with a short bore 25 in theproximal end of the outer tube 24 so that the two elements may betemporarily coupled together and slide together back and forth along achannel 13 of the housing between the distal wall 12 and a proximal wall14.

The pusher assembly 16 functions to deploy a self-cinching surgical clip30 out of the inner needle 28 of the device and prevent the clip frombacking out of the tissue or material. In this regard, a clip 30 isfirst loaded into the lumen of the inner needle 28 and the shaft 26 ofthe pusher assembly 16 advanced to locate the clip near the distal endof the needle 28, as seen in FIG. 3A. In this position, the coupledouter tube 24, inner needle 28 and graspable hub 22 are located to theleft (or distally) within the channel 13. While the clip 30 is withinthe inner needle 28, it is constrained in a substantially straightposition (or takes the shape of the inner needle 28 if that is notstraight).

Both the inner needle 28 and outer tube 24 guide the clip 30 from thehousing 18 into the tissue or material during deployment. FIG. 3B showsthe delivery step where the user displaces the inner needle 28 andgraspable hub 22 to the right a distance A along the channel 13, whichis about the clip length, while the pusher assembly 16 remains in placerelative to the housing 18. The pusher shaft 16 has a length Lsufficient to urge the clip 30 from the end of the inner needle 28. Theouter tube 24 also remains in place, preferably with a stop flange 32staying in contact with the tissue or material layer, as will beexplained.

FIGS. 4-5 present a detailed view of alternative embodiments of theouter tube 24 and the inner needle 28 of the delivery device 10. Outertube 24 is an elongate tube having the stop flange 32 positioned at itsdistal end and, in the illustrated embodiment, axial slot 34 thatextends from the stop flange a short distance proximally. The stopflange 32 prevents the outer tube 24 from penetrating the tissue ormaterial too deeply. Slot 34 may be present to allow the clip 30 toassume a curved shape once the clip 30 has reached a certain point ofdeployment within the inner needle 28, as will be explained in moredetail below.

As shown best in FIG. 4, in one particular embodiment the distal end ofthe inner needle 28 has a sharpened end 39 which assists in theinsertion of the inner needle 28 into the tissue or material. The term,“sharpened end” will be used herein to represent sharpened tips, whetherbeveled, tapered, or some other configuration. The sharpened end 39 ofthe inner needle 28 of the delivery system 10 is used to puncture thetissue and/or prosthetic device. This obviates the need for the end ofthe clip 30, which remains inside of the inner needle 28 of the deliverydevice 10, to be sharp, and it is thus desirably blunt. Therefore, nosharp ends remain in the patient's body once the clips 30 are deployed.This is important in reducing irritation of the surrounding tissue andincreases the safety of the clips 30 after implantation. It is wellknown that leaving clips or other devices in the body that have exposedsharp ends can cause irritation and necrosis of the surrounding tissue.Additionally, sharp tips have the potential to pierce other adjacentorgans and therefore present a risk. In a preferred embodiment the freeends of each clip have been ground so as to be rounded and not even haveright angle corners.

As shown in FIG. 6, the inner needle 28 of the delivery device 10 has aclip channel 42 to allow for passage and deployment of clip 30. In someembodiments, the clip channel 42 extends from a point between theproximal and distal ends of the inner needle 28 to the distal end of theinner needle 28. A single clip or multiple clips end-to-end in seriescan be pre-loaded within the inner needle 28 of the device prior to use.The combination of the outer tube 24 and inner needle 28 of FIGS. 4-6permit the clip 30 to exit laterally from within the inner needle 28,through the aligned axial slot 34 and clip channel 42, as will beexplained, in contrast to being ejected from a distal end as in FIGS.1-3.

FIGS. 7A and 7B are additional detailed illustrations of the clip 30 asit is deployed from the outer tube 24 and inner needle 28 of FIGS. 4-6.In this embodiment, as the clip 30 exits the inner needle 28, it is nolonger constrained in a straight position by the inner needle 28 and ittherefore relaxes into its “no-stress” state shown in FIGS. 8-10,depending on the clip embodiment utilized. Due to its ability to returnto its pre-shaped unconstrained closed-end shape, the clip 30 can bereferred to as self-closing. The interaction of the outer tube 24 andinner needle 28 is such that relative rotation of one with respect tothe other can alternately align and misalign the axial slot 34 and clipchannel 42, so as to control the timing of the clip ejection. That is,first the clip 30 is urged to the end of the inner needle 28, and thenthe axial slot 34 and clip channel 42 are aligned to permit the clip 30to curl and enter the target tissue or material layers.

As shown in FIGS. 8-10, the clips can have a variety of shapes in theirunstressed or unconstrained condition. Such shapes includesemicircle-shaped (FIG. 8), modified spiral (FIG. 9), and circular (FIG.10). The clip 30 is preferably made of a superelastic shape-memorymaterial such as Nitinol so that when unconstrained, the clips 30 areself-closing toward their no-stress configurations. In each of thepossible configurations, the clip 30 is designed such that when it isdeformed into a delivery configuration the strains in the clip 30 arebelow the yield point of the superelastic material. In allconfigurations, the clip 30 does not have any sharp ends or edges.

In some of the variations presented here, such as the semicircle-shapedclip type shown in FIG. 8, the two ends of the clip overlap whendeployed. This serves to reduce tissue irritation and increase theanchoring force to the tissue. In other embodiments, such as thecircular clip shown in FIG. 10, the clip ends come together afterdeployment, thereby eliminating any exposed ends and reducing thepotential for tissue irritation. The overlap of the two ends of thecircular clip of FIG. 10 may further reduce tissue irritation as well asincrease the holding force that can be generated by the clip. In otherembodiments, such as the spiral configuration shown in FIG. 9, the cliphas two open ends both terminating near the center of the clip.

The wire of the clips may have a round cross section, however, the crosssection could be other shapes including, but not limited to,rectangular, triangular, etc. The cross section shape and dimension ofthe clip wire could also vary along its length to create variableamounts of stiffness in different portions of the clip. For example,with respect to the spiral clip 30 shown in FIG. 9, stiffness can bevariable based upon the cross-sectional thickness, and the number andpitch of each individual coil. The overall shape of the clips couldchange as well and should not be considered limited to the three shapesdisclosed herein.

The deployment sequence of a particular embodiment utilizing a circularclip 30 is shown in FIG. 11. First, the surgical clip delivery device 10seen in FIG. 1 is advanced to the target site where the clip 30 is to bedeployed. The surgeon pierces the sharp end of the inner needle 28completely through the layers of tissue and/or synthetic materials to befastened together. The stop flange 32 prevents the outer tube 24 frompenetrating the tissue or material too deeply. Deployment of the clip 30occurs as the pusher assembly 16 (not shown, see FIG. 1) is advanceddistally toward the housing 18. In one particular embodiment, the distalend of the pusher shaft 26 is lined up end-to-end with the proximal endof the clip 30 within the inner needle 28 assembly. Distal advancementof the pusher shaft 26 therefore causing distal advancement of the clip30. In another particular embodiment, the pusher assembly 16 remainsstatic at the proximal end of the delivery device 10 as a stopper toprevent clip 30 from backing out of the proximal end of the inner needle28.

In yet another embodiment, to deploy the clip 30, the pusher assembly 16is advanced distally toward the housing 18 causing distal advancement ofthe clip 30 as described above. However, only a portion of the clip 30is deployed this way, the remaining portion being deployed when theinner needle 28 is retracted proximally. The pusher assembly 16 movesdistally a distance equal to only a portion of the length of the clip30, exposing that portion of the clip 30 on the distal side of thetissue layers. The entire device 10 is then retracted exposing theproximal end of the clip 30 on the proximal side of the target.Alternatively, the clip 30 can be advanced using any other tooladvancement mechanism known in the art.

Referring again to FIG. 11, the delivery sequence is as follows: thedelivery device 10 is positioned over, and the distal end of the innerneedle 28 pierces through, the target layers. The pusher assembly 16that displaces the clip 30 is advanced forward until the clip 30 iscompletely deployed. The delivery device 10 is then removed. In someembodiments, the clip 30 is restrained within the inner needle 28 andthe outer tube 24 until the tubes are rotated with respect to each otherand their respective slots 34 and 40 are aligned allowing the clip 30 tobe released from the tubes 28, 24.

Similarly, an example delivery sequence for the spiral clip 30 is shownin FIG. 12. In this particular embodiment, the device 10 is placed in alocation proximate the target layers. The inner needle 28, having asharpened and/or slanted end 39, pierces the target layers until thestop 32 hits the top layer. The clip 30 is deployed when the pusherassembly 16 (not shown) is advanced distally toward the housing 18. Thisaction causes the clip 30 to begin exiting the distal end of the innerneedle 28. As the clip 30 advances into the tissue, it begins to spiralaround the axis of the inner needle 28 on the opposite side of thelayers from the device 10. When the clip 30 is fully deployed, in oneparticular embodiment, portions of the clip 30 as well as the two endsof the clip are on opposite sides of the layers. In other embodiments,the ends may have varied final locations with respect to each other andvarying portions of the clip may be on either side of the layers beingheld together by the clip 30. In some embodiments, once a sufficientportion of the clip 30 is deployed on the opposite side of the layers,the inner needle 28 is removed from the layer before the clip 30 isfully deployed to allow a portion of the clip 30 to be on thedevice-side of the layers.

FIG. 13 illustrates an artificial heart valve implanted within theaortic valve annulus utilizing the device 10 and clips 30 describedherein. The prosthetic heart valve 50 is surgically inserted via theaorta 54 near the location of the native aortic heart valve annulus 52.The clip delivery device 10 is then inserted into the aorta 54 and theinner needle 28 first pierces the valve's securing ring and then thenative valve annulus 52. The clip 30 is deployed as described above inconnection with regarding FIGS. 11 and 12, securing the two layers(i.e., the valve's securing ring and the native valve annulus) together.Advantageously, the clips 30 shown in FIG. 13 were deployed entirelyfrom the outflow side of the valve. The device disclosed herein is ableto deliver the clips “blindly,” i.e. with access to only one side of thetarget.

To facilitate installation of a number of the clips 30, the deliverydevice may include a cartridge of clips that periodically increments topresent a new clip to be delivered. For example, FIGS. 14A-14C arecross-sectional views through an alternative clip delivery system 60having a cartridge 62 that holds multiple clips 30. As in thesingle-clip version of the surgical clip delivery device 10, the system60 has a housing 64 with a distal wall 66, a proximal wall 68, and achannel 70 therebetween and within which the cartridge 62 linearlyreciprocates. FIG. 15 is an elevational view of the cartridge 62. Acylinder 72 portion of the cartridge 62 rotates about a shaft extendingfrom a non-rotating portion 74. The inner needle 28 is connected to andextends away from the non-rotating portion 74 of the cartridge 62 intothe outer tube 24.

An assembly of a pusher handle 20′ and a pusher shaft 26′ are arrangedto be held at a proximal end of the housing channel 70 such that thepusher shaft extends through one of the cartridge chambers 76 andthrough the inner needle 28 lumen when the cartridge 62 is in itsproximal position. The pusher handle 20′ and a pusher shaft 26′ areremovable from the cartridge chamber 76 to permit the movable portion 72of the cartridge 62 to be repositioned to align a different chamber withthe inner needle 28, as will be explained.

In one particular embodiment, multiple clips 30, each in their owncartridge chamber 76, are arranged around the perimeter of the revolvingcylinder 72 portion of the cartridge 62, as shown in FIG. 15. Theassembly of the pusher handle 20′ and pusher shaft 26′ at the proximalend of the cylinder 72 are first removed, as in FIG. 14C, and then eachindividual chamber 76 is also brought into alignment one at a time. Thecylinder 72 revolves around the longitudinal axis of the system 60 whichallows alignment of each chamber with the clip channel of the innerneedle 28 for deployment. That done, the pusher handle 20′ and pushershaft 26′ are inserted again to move each clip 30 into the clip channelof the inner needle 28. FIG. 14B shows proximal movement of thecartridge 62 such that the pusher shaft 26′ ejects the clip 30 from theinner needle 28. The inner needle 28 and cartridge 62 move a distance Aapproximately equal to the length of each clip 30 in its straightenedshape and the clips curl toward their relaxed shapes when ejected. Theouter tube 24 remains in place, preferably with its stop flange stayingin contact with the target tissue or material layer. The next clip 30 isthen aligned via the rotation of the cylinder 72. The chambers may beinternal or external to the cylinder 72. This embodiment allows multipleclips 30 to be deployed without the user reloading the system 60.

While particular forms of the invention have been illustrated anddescribed, it will be apparent that various modifications can be madewithout departing from the spirit and scope of the invention. Forexample, in addition to the delivery device discussed herein, the clipsof the present invention could also be delivered though a catheter or alaparoscopic type instrument. The delivery system could also be modifiedsuch that the clips could be delivered through a flexible catheter. Thedelivery device could also be placed on the end of a long shaft fordelivery in a deep surgical incision such as an aortic valve replacementthrough a thoracotomy. Accordingly, it is not intended that theinvention be limited, except as by the appended claims.

What is claimed is:
 1. A method for securing a prosthetic heart valve toa native heart valve annulus, comprising the steps of: inserting aprosthetic heart valve having a securing ring to a native heart valveannulus such that the securing ring is in contact with the annulus;advancing a securing device toward the prosthetic heart valve, thesecuring device having an outer tube with a lumen and a stop flange on adistal end thereof, an inner needle having a sharpened end and sized andaligned to pass through the outer tube lumen and extend from the outertube stop flange, self-cinching clips made of a super-elastic materialheld in a substantially straight constrained configuration within alumen in the inner needle, a self-cinching clip having a non-linearrelaxed configuration when unconstrained, and a pusher shaft sized tofit through the inner needle lumen and expel the clip therefrom, whereinthe inner needle is mounted for movement along a channel in a housing,and the pusher shaft has a fixed position at a proximal end of thechannel such that proximal movement of the inner needle causes thepusher shaft to expel the clip from the inner needle, and wherein thesecuring device has a cartridge with a plurality of chambers each sizedto hold one of the self-cinching clips in its constrained configuration,the inner needle being attached to the cartridge and the entirecartridge being movable along the housing channel between a distalposition and a proximal position; puncturing the prosthetic heart valvesecuring ring and native heart valve annulus using the sharpened end ofthe inner needle until the stop flange contacts the securing ring andthe inner needle projects beyond a distal side of the annulus; partiallyexpelling the clip from the inner needle using the pusher shaft so thata portion of the clip beyond the distal side of the annulus returns toits relaxed configuration; withdrawing the inner needle to a proximalside of the securing ring; fully expelling the clip from the innerneedle so that a portion of the clip on the proximal side of thesecuring ring returns to its relaxed configuration, thus holding thesecuring ring against the annulus; and repeating the steps ofpuncturing, partially expelling, withdrawing and fully expelling todeploy multiple clips around the securing ring, including sequentiallyaligning different chambers with the pusher shaft and inner needle tosequentially deploy multiple clips.
 2. The method of claim 1, whereinthe native heart valve annulus is an aortic valve annulus, and thesecuring device is advanced along an aorta and the clips are deployedentirely from an outflow side of the valve.
 3. The method of claim 1,wherein the self-cinching clip, in its relaxed configuration, has aspiral shape having two open ends terminating at different locations. 4.The method of claim 1, wherein the self-cinching clip, in its relaxedconfiguration, has a circular shape with two ends terminating atapproximately the same location.
 5. The method of claim 1, wherein theself-cinching clip, in its relaxed configuration, has a semicircle shapewith two ends terminating at approximately the same location.
 6. Themethod of claim 1, wherein the securing device has a cartridge with aplurality of chambers each sized to hold one of the self-cinching clipsin its constrained configuration, and the method includes sequentiallyaligning different chambers with the inner needle to sequentially deploymultiple clips.
 7. The method of claim 1, wherein the cartridge has aproximal portion rotatable about a central axis parallel to aproximal/distal direction and relative to a distal portion to which theinner needle attaches, the distal portion having a throughbore alignedwith the inner needle lumen and aligned with sequential chambers whenthe proximal portion rotates, and wherein the pusher shaft is insertableand removable from the cartridge chambers to permit the proximal portionof the cartridge to rotate to align different cartridge chambers withthe pusher shaft and throughbore and inner needle lumen, the methodincluding sequentially rotating the proximal portion of the cartridge toalign different chambers with the inner needle lumen and sequentiallydeploy multiple clips.
 8. A method for securing a prosthetic heart valveto a native heart valve annulus, comprising the steps of: inserting aprosthetic heart valve having a securing ring to a native heart valveannulus such that the securing ring is in contact with the annulus;advancing a securing device toward the prosthetic heart valve, thesecuring device having an outer tube with a lumen and a stop flange on adistal end thereof, the outer tube also having an axial slot thatextends to the stop flange, an inner needle having a sharpened end andsized and aligned to pass through the outer tube lumen and extend fromthe outer tube stop flange, the inner needle having a clip channel thatextends to the sharpened end and being rotatable with respect to theouter tube, a self-cinching clip made of a super-elastic material heldin a substantially straight constrained configuration within a lumen inthe inner needle, the clip having a non-linear relaxed configurationwhen unconstrained, and a pusher shaft sized to fit through the innerneedle lumen and expel the clip therefrom; puncturing the prostheticheart valve securing ring and native heart valve annulus using thesharpened end of the inner needle until the stop flange contacts thesecuring ring and the inner needle projects beyond a distal side of theannulus; advancing the clip through the inner needle using the pushershaft until the clip is located adjacent the clip channel in the innerneedle and the axial slot in the outer tube; rotating the outer tube toalign the clip channel in the inner needle and the axial slot in theouter tube so that a portion of the clip beyond the distal side of theannulus returns to its relaxed configuration and a portion of the clipon the proximal side of the securing ring returns to its relaxedconfiguration, thus holding the securing ring against the annulus; andrepeating the steps of puncturing, partially expelling, withdrawing andfully expelling to deploy multiple clips around the securing ring. 9.The method of claim 8, wherein the native heart valve annulus is anaortic valve annulus, and the securing device is advanced along an aortaand the clips are deployed entirely from an outflow side of the valve.10. The method of claim 8, wherein the self-cinching clip, in itsrelaxed configuration, has a circular shape with two ends terminating atapproximately the same location.
 11. The method of claim 8, wherein theself-cinching clip, in its relaxed configuration, has a semicircle shapewith two ends terminating at approximately the same location.
 12. Themethod of claim 8, wherein the securing device has a cartridge with aplurality of chambers each sized to hold one of the self-cinching clipsin its constrained configuration, and the method includes sequentiallyaligning different chambers with the inner needle to sequentially deploymultiple clips.
 13. The method of claim 8, wherein the inner needle ismounted for movement along a channel in a housing, and the pusher shafthas a fixed position at a proximal end of the channel such that proximalmovement of the inner needle causes the pusher shaft to advance the clipthrough the inner needle.
 14. The method of claim 13, wherein thesecuring device has a cartridge with a plurality of chambers each sizedto hold one of the self-cinching clips in its constrained configuration,the inner needle being attached to the cartridge and the entirecartridge being movable along the housing channel between a distalposition and a proximal position, and the method includes sequentiallyaligning different chambers with the inner needle to sequentially deploymultiple clips.
 15. The method of claim 14, wherein the cartridge has aproximal portion rotatable about a central axis parallel to aproximal/distal direction and relative to a distal portion to which theinner needle attaches, the distal portion having a throughbore alignedwith the inner needle lumen and aligned with sequential chambers whenthe proximal portion rotates, and wherein the pusher shaft is insertableand removable from the cartridge chambers to permit the proximal portionof the cartridge to rotate to align different cartridge chambers withthe pusher shaft and throughbore and inner needle lumen, the methodincluding sequentially rotating the proximal portion of the cartridge toalign different chambers with the inner needle lumen and sequentiallydeploy multiple clips.